Aarti Pharmalabs Limited announced the completion of a US FDA inspection at its Tarapur Unit-IV facility. The inspection concluded on March 27, 2026, with the issuance of a Form 483 containing one procedural observation. The company will submit corrective and preventive actions within the stipulated timeline.
Aarti Pharmalabs Limited has informed the stock exchanges about the outcome of the US FDA inspection at its Tarapur Unit-IV site. The inspection ended with a single procedural observation, underscoring the company’s commitment to compliance and regulatory transparency.
Inspection Outcome
The United States Food and Drug Administration (US FDA) conducted an inspection at Unit-IV, Tarapur, Maharashtra. At the conclusion, a Form 483 was issued with one observation, which the company clarified was procedural in nature.
Corrective Measures
Aarti Pharmalabs confirmed that corrective and preventive actions (CAPA) will be submitted to the US FDA within the required timeframe, ensuring adherence to global regulatory standards.
Key Highlights
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US FDA inspection completed at Tarapur Unit-IV
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Form 483 issued with one procedural observation
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CAPA submission planned within stipulated period
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Disclosure made under SEBI Listing Regulations
Sources: Aarti Pharmalabs Ltd Press Release